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Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04461769
Acronym
ESSOTEDS
Enrollment
13
Registered
2020-07-08
Start date
2019-09-01
Completion date
2020-05-30
Last updated
2020-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep, Sleep Hygiene

Brief summary

This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.

Detailed description

Previous studies have demonstrated successful synchronization of SOs with slow TES pulses. However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3, F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from frontal neocortex. In the present study, we hypothesized that transcranial electrical stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3 sleep. Furthermore, based on our computational modeling with this more optimal targeting of the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1 or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.

Interventions

DEVICETranscranial Electrical Stimulation

Oscillating electrical current

Sponsors

Brain Electrophysiology Laboratory Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Participants were blind to which night was stimulation. Experimenters were blinded until the participant was asleep, when they opened an email that specified delivery of stimulation or sham.

Intervention model description

First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

\-

Exclusion criteria

* history of seizures * epilepsy * brain trauma or injury * insomnia * sleep apnea * medications that may affect the EEG.

Design outcomes

Primary

MeasureTime frameDescription
N3 DurationMeasured during the night of sleep (typically 8 hours)Duration in minutes of N3 sleep

Secondary

MeasureTime frameDescription
N3 PercentageMeasured during the night of sleep (typically 8 hours)Percentage of the night's sleep spent in N3

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026